14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ALTRA PRESS-FIT HIP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Trulife
FDA UDI
Trulife Limited·00645517723716·ActiveFlow External Breast Form Size 02
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00630021·
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040005866·Ortho Bracket Adhes Kit
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
FDA 510(k)
FDA Class 1
·Clinical Toxicology
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
FDA 510(k)
FDA Class 2
·General Hospital
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
M2A MAGNUM MODULAR HD COCR 44MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·April 17, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2011
COBAS E411 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·June 18, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018